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Volume 16, Number 8–August 2010
About the Cover
Not from the Stars Do I My Judgment Pluck1
Polyxeni Potter*
*Centers for Disease Control and Prevention, Atlanta, Georgia, USA
Suggested citation for this article


Vincent van Gogh (1853–1890) Terrace of a Café at Night (Place du Forum) (c. 18 September 1888) Oil on canvas (80.7 cm × 65.3 cm) Courtesy of Kröller-Müller Museum, Otterlo, the Netherlands


"It amuses me enormously to paint the night right on the spot," wrote Vincent van Gogh to his brother Theo. "Normally, one draws and paints the painting during the daytime after the sketch. But I like to paint the thing immediately. It is true that in the darkness I can take a blue for a green, a blue lilac for a pink lilac, since it is hard to distinguish the quality of the tone. But it is the only way to get away from our conventional night with poor pale whitish light …." Despite this affection for the night, van Gogh described Night Café, one of his best known night paintings, as "one of the ugliest I have done." Though he loved the purity of the night outdoors, he loathed urban night life. "I have attempted to show that the café is a place where a man can ruin himself, become mad, commit a crime…." He moved away from Paris, where he lived with Theo, to Arles, "wishing to see a new light" and explore the calm.

In Paris he had come to know the impressionists and to experiment with broken brushstrokes and the style of the pointillists Georges Seurat and Paul Signac. He studied with Fernand Cormon and made friendships and contacts in the art world. His palette was transformed, from dark tones and stillness to yellows and blues and swirling lines. Yet, "When I left you at the station to go south," he told Theo, "I was very miserable, almost an invalid and almost a drunkard. Now at last something is beginning to show on the horizon: Hope." Moving to the countryside was an effort to get in touch with a more authentic way to live, to focus on ideas and nourish the spirituality he long sought, first as a student at the seminary and then in art.

The simplicity of rural life appealed to him on another level. "I will begin by telling you that this country seems to me as beautiful as Japan as far as the limpidity of the atmosphere and the gay color effects are concerned." Like many of his contemporaries, van Gogh was fascinated with art from the Orient. He collected and copied woodblock prints and welcomed Utagawa Hiroshige and Katsushika Hokusai into the western vernacular. "My whole work … builds so to speak on what the Japanese have done." Under their influence, he moved toward color and away from naturalism, volume and perspective, light and shadow. "I envy the Japanese artists for the incredible neat clarity which all their works have. It is never boring and you never get the impression that they work in a hurry. It is as simple as breathing; they draw a figure with a couple of strokes … as if it were as easy as buttoning one's waistcoat."

Van Gogh's meteoric rise to greatness in the so-brief span of his 37 years took place in various settings and was marked by emotional turmoil, from unrequited love and failure at evangelism to familial strife and poverty. Through it all, he assessed his own legacy as "of very secondary importance." Largely self-taught, he absorbed brief but potent influences. He took his first artistic steps in his native Holland, copying from art books, working as apprentice for an art dealer at age 16. He received formal instruction from leading Hague School artist Anton Mauve, then moved to London, where he taught school for a couple of years. He became interested in the Barbizon group, particularly Jean-François Millet, and started to paint peasants and rural life, a practice he would continue throughout his life. He traveled to Belgium to study at the Antwerp Academy, an unsuccessful venture, and soon after went to live with Theo in Paris. He took up painting in earnest in 1880 and continued until his death, producing in 10 years 900 paintings and more than 1,100 works on paper. Some of his masterpieces were created during the past 2 years of life when, overcome by mental illness, he committed himself to the asylum in Saint-Rémy. "I put my heart and my soul into my work and have lost my mind in the process."

The evening and night, recurring themes in van Gogh's work, interested him even before he began to paint. As a youth he was an avid reader, fluent in Dutch, German, English, and French. Many of the books he mentioned in his letters described the spiritual and poetic character of the night, the interval between sunset and dark, and the darkness between dusk and dawn. "It seems to me that the night is more alive and richly colored than the day." This time for reflection and introspection sparked his artistic imagination and produced, among other major works, The Starry Night; Landscapes at Twilight; Peasant Life at Evening; Poetry of the Night; and Terrace of a Café at Night, on this month's cover, a painting reminiscent of Hiroshige's Scene of the Saruwaka-cho Theater Street by Night.

"On the terrace there are small figures of people drinking," van Gogh wrote to his brother about this his first starry painting of an outdoor café. "An immense yellow lantern illuminates the terrace, the facade, the sidewalk, and even casts light on the paving stones of the road, which take a pinkish violet tone. The gables of the houses, like a fading road below a blue sky studded with stars, are dark blue or violet with a green tree." Excited about the results, he explained to Theo, "Here you have a night painting without black, with nothing but beautiful blue and violet and green and in this surrounding the illuminated area colors itself sulfur pale yellow and citron green."

In this and other night paintings, he struggled to achieve luminosity with contrasting or exaggerated colors and to demonstrate the superiority of natural light and the imagination over artificial light and reality. He struggled equally to express the mysterious influence of the night on the human heart as he understood it from his own tumultuous life. "I am a man of passion, capable and prone to undertake more or less foolish things which I happen to repent more or less." While he worked on his first painting of a starry night, he wrote, "It is good for me to work hard. But that does not keep me from having a terrible need of―shall I say the word―yes, of religion. Then I go out at night to paint the stars."

This need went back to van Gogh's days as evangelist in an impoverished mining town in Belgium. He was dismissed from that post for showing extreme charity and identifying too much with the flock. His religious zeal dampened, he vowed then to make art for the common people, to paint them and their concerns. And who among the common people has not gazed upward wishing to decipher the mysteries of the sky? "Looking at the stars always makes me dream," he wrote, "Why, I ask myself, shouldn't the shining dots of the sky be as accessible as the black dots on the map of France?" Like others throughout the ages, he sought solace in the stars' mysterious light and viewed them as symbols of hope. "Just as we take the train to get to Tarascon or Rouen, we take death to reach a star."

The stars, and their influence on human life― domain of the scientist, let alone the lover and the poet―have roots in antiquity and were examined long before van Gogh swirled them down to earth for all to see. In the 14th century, Italian physicians ascribed a mysterious illness often turned epidemic to the adverse influence of the stars and called it influentia. The term influenza was first used in English in 1743 during an outbreak of the disease in Europe. Despite our continued inability to prevent its global spread, we have learned since that viruses are the culprits and that influenza has less to do with ethereal substances emanating from the stars and more with tiny droplets shared generously between patrons under the café awning and in other gathering places. We are still just as intrigued with the stars and van Gogh's interpretations. And we have astronomy, as the Bard put it, "But not to tell of good or evil luck, / Of plagues, of dearths, or seasons' quality."

Bibliography
1.Blumer D. The illness of Vincent van Gogh. Am J Psychiatry. 2002;159:519–26. PubMed DOI: 10.1176/appi.ajp.159.4.519
2.Druick DW, Kort ZP. Van Gogh and Gauguin: the studio of the South. New York: Thames and Hudson; 2002.
3.Gift TL, Palekar RS, Sodha SV, Kent CK, Fagan RP, Archer WR, et al. Household effects of school closure during pandemic (H1N1) 2009, Pennsylvania, USA. Emerg Infect Dis. 2010;16:1315–7.
4.Kendall R. Van Gogh's van Goghs: masterpieces from the van Gogh Museum, Amsterdam. Washington: National Gallery of Art; 1998.
5.The complete letters of Vincent van Gogh. 3 vols. Boston: Bullfinch Press of Little Brown and Co; 2000.
6.Van Gogh and the colors of the night [cited 2010 Jun 14]. http://www.moma.org/interactives/exhibitions/2008/vangoghnight/flashsite/index.html
Suggested Citation for this Article
Potter P. Not from the stars do I my judgment pluck. Emerg Infect Dis [serial on the Internet]. 2010 Aug [ date cited]. http://www.cdc.gov/EID/content/16/8/zzz.htm


DOI: 10.3201/eid1608.000000

1William Shakespeare, Sonnet 14.

Vol. 16, No. 7 Cover: Cover Title | CDC EID

Current Issue: Table of Contents
Volume 16, Number 8–August 2010

Perspectives
Hantavirus Infections in Humans and Animals, China
Y.-Z. Zhang et al.

Synopsis
Medscape CME Activity
Clostridium difficile Bacteremia, Taiwan
N.-Y. Lee et al.

Research
Responses to Pandemic (H1N1) 2009, Australia
K. Eastwood et al.

Bat Coronaviruses and Experimental Infection of Bats, the Philippines
S. Watanake et al.

Multiyear Surveillance for Avian Influenza Virus in Waterfowl from Wintering Grounds, Texas Coast
P. Ferro et al.

Corynebacterium pseudodiphtheriticum in Cystic Fibrosis Patients, France
F. Bittar et al

White-Nose Syndrome Fungus in Bats, Europe
G. Wibbelt et al.

Scavenging Ducks and Transmission of Highly Pathogenic Avian Influenza, Indonesia
J. Henning et al.

West Nile Virus Range Expansion into British Columbia
D. Roth et al.

Pandemic (H1N1) 2009 Surveillance, New York, New York, April–July 2009
S. Balter et al.

Medscape CME Activity
Pandemic (H1N1) 2009 Viral Load, Disease Severity and Virus Shedding in Children
C.-C. Li et al.

Historical Review
Pearl Kendrick, Grace Eldering, and the Pertussis Vaccine
C. Shapiro-Shapin

Dispatches
Duck Hunters’ Perceptions of Risk for Avian Influenza, Georgia
H. Dishman et al.

Amblyomma imitator Ticks as Vectors of Rickettsia rickettsii, Mexico
K.A. Oliveira et al.

Bat Rabies in Massachusetts, 1985–2009
X. Wang et al.

Lyme Borreliosis, Po River Valley, Italy
D. Pistone et al.

Pandemic (H1N1) 2009 Surveillance in Marginalized Populations, Tijuana, Mexico
T. Rodwell et al.

Novel Mycobacterium tuberculosis Complex Pathogen, M. mungi
K. Alexander et al.

Quarantine Methods and Prevention of Secondary Outbreak of Pandemic (H1N1) 2009
C.-Y. Chu et al.

Picornavirus Salivirus/Klassevirus in Children with Diarrhea, China
T. Shan

Human Rickettsia heliogjiangensis Infection, Japan
S. Ando et al.

Pandemic (H1N1) 2009 Vaccination and Class Suspensions After Outbreaks, Taiwan
P.-R. Hsueh et al.

Pandemic (H1N1) 2009 Virus in Down Syndrome Patients
R. Perez-Padilla et al.

Effects of School Closures during Pandemic (H1N1) 2009, Pennsylvania
T. Gift et al.

Letters

Imported Human Rabies, the Philippines and Finland, 2007
R. Rimhanen-Finne et al.

An Eye-Opening Approach to Norovirus Surveillance
A. Hulth et al

Possible Recurrent Pandemic (H1N1) 2009 Infection, Israel
E. Kopel et al.

Novel Chlamydia-like Organisms as Cause of Bovine Abortion, UK
N. Wheelhouse et al.

West Nile Virus Knowledge among Hispanics, San Diego County, California, 2006
J. Bethel and S. Waterman

Crimean-Congo Hemorrhagic Fever in Man, Republic of Georgia, 2009
K. Zakhashvili et al.

Mycobacterium avium subsp. hominissuis Infection in Horses
P. Kriz et al.

Lethal Necrotizing Pneumonia Caused by an ST398 Staphylococcus aureus Strain
J.-P. Rasigade et al.

Not-So-Novel Michigan Rabbit Calicivirus (response)
J. Abrantes and P. Esteves

Leptospira Serovar as a Prognostic Factor (response)
M. Suzuki and K. Ariyoshi

Book Review
The Dictionary of Virology, 4th Edition
A. Brault

Conference Summary
One Health Approach to Influenza: Assessment of Critical Issues and Options
T. F. Powdrill et al.
Cover

Not from the Stars Do I My Judgement Pluck
P. Potter

News and Notes
Etymologia: Bordetella pertussis

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Consultas totales conjuntas (todos los blogs): 776.985

Discriminadas como sigue:
1. ARGENTINA: 33.037 [15,8%]
2. ESPAÑA: 32.659 [15,6%]
3. MÉXICO: 28.976 [13,8%]
4. U.S.A.: 22.235 [10,6%]
5. COLOMBIA: 12.206 [ 5.8%]
6. VENEZUELA: 12.120 [ 5,8%]
7. PERÚ: 12.073 [ 5,7%]
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NOTA DEL BLOG: durante el MES DE AGOSTO 2010 no tendremos actividad durante la semana que se extiende entre el día 22 y 28 del mismo mes. En dicho lapso se desarrollarán las Jornadas de Salud en la ciudad de Rosario (Provincia de Santa Fé) bajo la consigna: “Salud en el Tercer Centenario”.

Vital Signs: Breast Cancer Screening Among Women Aged 50--74 Years --- United States, 2008

Vital Signs: Breast Cancer Screening Among Women Aged 50--74 Years --- United States, 2008
Weekly
July 9, 2010 / 59(26);813-816


On July 6, this report was posted as an MMWR Early Release on the MMWR website (http://www.cdc.gov/mmwr).

ABSTRACT
Background: Breast cancer remains the second leading cause of cancer deaths for women in the United States. Screening with treatment has lowered breast cancer mortality.

Methods: Every 2 years, CDC uses Behavioral Risk Factor Surveillance System data to estimate mammography prevalence in the United States. Up-to-date mammography prevalence is calculated for women aged 50--74 years who report they had the test in the preceding 2 years.

Results: For 2008, overall, age-adjusted, up-to-date mammography prevalence for U.S. women aged 50--74 years was 81.1%, compared with 81.5% in 2006. Among the lowest prevalences reported were those by women aged 50--59 years (79.9%), persons who did not finish high school (72.6%), American Indian/Alaska Natives (70.4%), those with annual household income <$15,000 (69.4%), and those without health insurance (56.3%). Highest mammography prevalence was among residents of the northeastern United States.

Conclusions: In recent years, mammography rates have plateaued. Critical gaps in screening remain for certain racial/ethnic groups and lower socioeconomic groups, and for the uninsured.

Implications for Public Health Practice: Health-care reform is likely to increase access by increasing insurance coverage and by reducing out-of-pocket costs for mammography screening. Widespread implementation of evidence-based interventions also will be needed to increase screening rates. These include patient and provider reminders to schedule a mammogram, use of small media (e.g., videos, letters, brochures, and flyers), one-on-one education of women, and reduction of structural barriers (e.g., more convenient hours and attention to language, health literacy, and cultural factors).

Breast cancer remains the most commonly diagnosed cancer and the second leading cause of cancer deaths among women in the United States. In 2006 (the most recent data available), approximately 191,410 women were diagnosed with invasive breast cancer, and 40,820 women died (1). The incidence and mortality have been declining since 1996 at a rate of approximately 2% per year (2), possibly as a result of widespread screening with mammography and the development of more effective therapies (3). Mammography use declined slightly in 2004, but rose again in 2006 (4,5). This Vital Signs report updates mammography screening prevalence in the United States, using data from the 2008 Behavioral Risk Factor Surveillance System (BRFSS).

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Vital Signs: Breast Cancer Screening Among Women Aged 50--74 Years --- United States, 2008

Vital Signs: Colorectal Cancer Screening Among Adults Aged 50--75 Years --- United States, 2008

Vital Signs: Colorectal Cancer Screening Among Adults Aged 50--75 Years --- United States, 2008
Weekly
July 9, 2010 / 59(26);808-812


CDC Vital Signs is a new series of MMWR reports that will announce the latest results for key public health indicators.

On July 6, this report was posted as an MMWR Early Release on the MMWR website (http://www.cdc.gov/mmwr).

ABSTRACT
Background: Colorectal cancer (CRC) remains the second leading cause of cancer deaths in the United States and the leading cause of cancer deaths among nonsmokers. Statistical modeling indicates that, if current trends in health behaviors, screening, and treatment continue, U.S. residents can expect to see a 36% decrease in the CRC mortality rate by 2020, compared with 2000.

Methods: Every 2 years, CDC uses Behavioral Risk Factor Surveillance System data to estimate up-to-date CRC screening prevalence in the United States. Adults aged ≥50 years were considered to be up-to-date with CRC screening if they reported having a fecal occult blood test (FOBT) within the past year or lower endoscopy (i.e., sigmoidoscopy or colonoscopy) within the preceding 10 years. Prevalence was calculated for adults aged 50--75 years based on current U.S. Preventive Services Task Force recommendations.

Results: For 2008, the overall age-adjusted CRC screening prevalence for the United States was 62.9% among adult respondents aged 50--75 years, increased from 51.9% in 2002. Among the lowest screening prevalences were those reported by persons aged 50--59 years (53.9%), Hispanics (49.8%), persons with lower income (47.6%), those with less than a high school education (46.1%), and those without health insurance (35.6%).

Conclusions: CRC screening rates continue to increase in the United States. Underscreening persists for certain racial/ethnic groups, lower socioeconomic groups, and the uninsured.

Implications for Public Health Practice: Health reform is anticipated to reduce financial barriers to CRC screening, but many factors influence CRC screening. The public health and medical communities should use methods, including client and provider reminders, to ensure test completion and receipt of follow-up care. Public health surveillance should be expanded and communication efforts enhanced to help the public understand the benefits of CRC screening.

Despite recent declines in both incidence and mortality, colorectal cancer (CRC) remains the second most common cause of cancer deaths after lung cancer in the United States (1) and the leading cause of cancer deaths among nonsmokers. In 2006 (the most recent data available), 139,127 people were diagnosed with colorectal cancer, and 53,196 people died (1). Screening for colorectal cancer is effective in reducing incidence and mortality by removal of premalignant polyps and through early detection and treatment of cancer (2). CRC screening prevalence has improved over the past decade (3); however, in 2006, approximately 30% of eligible U.S. residents had never been screened for CRC (3). This Vital Signs report updates screening prevalence in the United States using data from the 2008 Behavioral Risk Factor Surveillance System (BRFSS) survey for persons aged 50--75 years, based on recommendations for up-to-date CRC screening from the U.S. Preventive Services Task Force (USPSTF) (4).

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Vital Signs: Colorectal Cancer Screening Among Adults Aged 50--75 Years --- United States, 2008

CDC - Blogs - Safe Healthcare - Today’s CMS Rule: A Major Step for HAI Reporting (Part 1 of 6)

Today’s CMS Rule: A Major Step for HAI Reporting (Part 1 of 6)
July 30th, 2010 1:59 pm ET -



Michael Bell, MD
-Mike Bell, MD
Deputy Director, Division of Healthcare Quality Promotion, CDC

It’s a new day in our efforts to eliminate healthcare-associated infections (HAI)s. A rule released today by the Centers for Medicare & Medicaid Services (CMS) lays out HAI reporting requirements for Medicare eligible hospitals that participate in CMS’ pay-for-reporting program. More than 3,500 hospitals will soon use CDC’s National Healthcare Safety Network (NHSN) to report central line-associated bloodstream infection (CLABSI) and surgical site infection (SSI) data to CMS. In turn, the agency will post the information on the HHS publicly accessible Hospital Compare Web site.

The release from CMS today is yet another sign that HAIs are recognized as a significant measure of healthcare quality. It is encouraging to see CMS build upon its work in preventing healthcare-acquired conditions, including HAIs.

So, what does this mean in practice?

For healthcare facilities – it connects financial incentives to HAI reporting. In other words, facilities that report will be recognized and rewarded for their efforts. We expect that this change will fuel existing momentum toward HAI prevention and elimination programs already happening within healthcare facilities across the country.

For patients – it is an excellent way to see how their hospital is doing on several quality of care issues, including preventing infections. It will be the first time patients from all states can view the infection data from their local hospitals. This information can serve as a discussion point between patients and their healthcare providers.

For our healthcare system – it increases our accountability and transparency. Data on HAIs can drive our prevention initiatives. When we know where infections are occurring, we can work to prevent them and protect patients.

To implement this rule, we will start with a phased approach. In 2011, CLABSI data will be reported, and we are starting with the most vulnerable patients – those in intensive care units and neonatal intensive care units. In 2012, data from surgical site infections (SSIs) will be reported. We expect to expand further in coming years.

It will be critical for facilities to take a team approach. Hospitals will need to rely strongly on their infection preventionists and healthcare epidemiologists, as well as all practicing clinicians. In our next several blog posts, you will hear from infection preventionists, healthcare epidemiologists, clinicians, and consumers on their perspective of this new rule.

In the meantime, tell us your thoughts.

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CDC - Blogs - Safe Healthcare - Today’s CMS Rule: A Major Step for HAI Reporting (Part 1 of 6)

Studies in Support of Special Populations: Geriatrics

ICH topic E7
Studies in Support of Special Populations: Geriatrics
Questions and Answers
Step 5

July 2010
EMA/CHMP/ICH/604661/2009
Committee for medicinal products for human use (CHMP)

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http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500005218.pdf

STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS

STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS
ICH Harmonised Tripartite Guideline

1. STATEMENT OF PURPOSE
It is important to ensure that clinical testing programs are carried out according to harmonised guidelines based on agreed ethical and scientific principles so that the international development of valuable innovative drugs is achieved with maximum efficiency.

Harmonisation in relation to medicines for geriatric populations is an important issue because the total population of the elderly will increase significantly in the coming years in Europe, Japan and the USA. The use of drugs in this population requires special consideration due to the frequent occurrence of underlying diseases, concomitant drug therapy and the consequent risk of drug interaction.

2. GENERAL PRINCIPLE
Drugs should be studied in all age groups, including the elderly, for which they will have significant utility. Patients entering clinical trials should be reasonably representative of the population that will be later treated by the drug.

3. SCOPE OF GUIDELINE
This guideline is directed principally toward new Molecular Entities that are likely to have significant use in the elderly, either because the disease intended to be treated is characteristically a disease of aging ( e.g., Alzheimer's disease) or because the population to be treated is known to include substantial numbers of geriatric patients (e.g., hypertension).

The guideline applies also to new formulations and new combinations of established
medicinal products when there is specific reason to expect that conditions common in the elderly (e.g., renal or hepatic impairment, impaired cardiac function, concomitant illnesses or concomitant medications) are likely to be encountered and are not already dealt with in current labelling. It likewise applies when the new formulation or new combination is likely to alter the geriatric patient's response (with regard to either safety/ tolerability or efficacy) compared with that of the non-geriatric patient in a way different from previous formulations.

The guideline also applies to new uses that have significant potential applicability to the elderly.

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http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002875.pdf

Dissolving polymer microneedle patches for influenza vaccination : Nature Medicine : Nature Publishing Group

Nature Medicine | Technical Report

Dissolving polymer microneedle patches for influenza vaccination
Sean P Sullivan,Dimitrios G Koutsonanos,Maria del Pilar Martin,Jeong Woo Lee,Vladimir Zarnitsyn,Seong-O Choi,Niren Murthy,Richard W Compans,Ioanna Skountzou& Mark R Prausnitz

AffiliationsContributionsCorresponding authors Journal name:
Nature Medicine
Year published:
(2010)
DOI:
doi:10.1038/nm.2182
Received30 July 2009
Accepted23 April 2010
Published online18 July 2010
Abstract

Influenza prophylaxis would benefit from a vaccination method enabling simplified logistics and improved immunogenicity without the dangers posed by hypodermic needles. Here we introduce dissolving microneedle patches for influenza vaccination using a simple patch-based system that targets delivery to skin's antigen-presenting cells. Microneedles were fabricated using a biocompatible polymer encapsulating inactivated influenza virus vaccine for insertion and dissolution in the skin within minutes. Microneedle vaccination generated robust antibody and cellular immune responses in mice that provided complete protection against lethal challenge. Compared to conventional intramuscular injection, microneedle vaccination resulted in more efficient lung virus clearance and enhanced cellular recall responses after challenge. These results suggest that dissolving microneedle patches can provide a new technology for simpler and safer vaccination with improved immunogenicity that could facilitate increased vaccination coverage.



Figures at a glance


leftFigure 1: Dissolving polymer microneedle patches.
(a) Side view of dissolving polymer microneedles. (b) Relative height of an array of microneedles next to a US nickel coin. (c) En face view of porcine cadaver skin after insertion and removal of microneedles, showing delivery of the encapsulated compound (sulforhodamine). (d) Fluorescence micrograph of pig skin histological section after insertion of dissolving microneedles ex vivo. (e) Brightfield micrograph of the same skin section with H&E staining.


Figure 2: Delivery to skin using microneedles.
(a) Polymer microneedle dissolution in pig skin ex vivo. Top, before insertion; middle, remaining polymer 1 min after insertion in skin; bottom, remaining polymer 5 min after insertion in skin. (b) Dissolving microneedle delivery efficiency to mice in vivo. Sulforhodamine was encapsulated within microneedles and administered to mice (n = 5 for each time point). The delivery efficiencies for the three time points were statistically different from one another (Student's t test, P < 0.05). (c) Effect of PVP and lyophilization on vaccine immunogenicity. Mice (n = 3) were immunized i.m. with 20 μg inactivated influenza virus (A/PR/8/34) that was either lyophilized or in solution with or without PVP added. Serum IgG antibody titers and HAI were measured 14 d after immunization. Unproc., unprocessed inactivated influenza virus in PBS; Lyo., lyophilized inactivated influenza virus redissolved in PBS; Unproc. + PVP, unprocessed inactivated influenza virus in PBS mixed with PVP; Lyo. + PVP, lyophilized inactivated influenza virus encapsulated in PVP; N, naïve mice. Error bars represent s.d. from three to five independent experiments.


Figure 3: Microneedle immunization studies.

These authors contributed equally to this work.
Sean P Sullivan & Dimitrios G Koutsonanos

Affiliations
Wallace H. Coulter Department of Biomedical Engineering at Emory University and Georgia Tech, Georgia Institute of Technology, Atlanta, Georgia, USA.
Sean P Sullivan,Niren Murthy &Mark R Prausnitz
Department of Microbiology & Immunology and Emory Vaccine Center, Emory University School of Medicine, Atlanta, Georgia, USA.
Dimitrios G Koutsonanos,Maria del Pilar Martin,Richard W Compans &Ioanna Skountzou
School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, Georgia, USA.
Jeong Woo Lee,Vladimir Zarnitsyn,Seong-O Choi &Mark R Prausnitz

Contributions
S.P.S., D.G.K., M.d.P.M. and I.S. carried out most experimental studies; J.W.L. and V.Z. prepared microneedles and helped generate the Supplementary Data; S.-O.C. prepared the molds used to fabricate microneedles; S.P.S., D.G.K., I.S. and M.R.P. designed the study and its analysis; S.P.S., I.S. and M.R.P. wrote the manuscript; and N.M., R.W.C., I.S. and M.R.P. supervised the project.

Competing financial interests
M.R.P. serves as a consultant to and is an inventor on patents licensed to companies developing microneedle-based products. This possible conflict of interest is being managed by Georgia Tech and Emory University.

Corresponding authors
Correspondence to:
Mark R Prausnitz (prausnitz@gatech.edu) or Ioanna Skountzou (iskount@emory.edu)

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Dissolving polymer microneedle patches for influenza vaccination : Nature Medicine : Nature Publishing Group

Flu Shots No More?

Flu (Influenza)Flu Shots No More?
NIAID Grantees Use New Skin Patches to Deliver Flu Vaccine in Mice

You’ve probably heard of patches for delivering nicotine-replacement therapy or hormones for birth control. But what about other uses, such as vaccination? For many years, researchers have been working to find a way to deliver flu vaccine – whose components are much larger than those of nicotine and hormones – using a transdermal (across the skin) patch. One method, developed by scientists at the Georgia Institute of Technology and Emory University, uses a new type of patch made of dissolving microneedles, which are tiny, painless needles that allow flu vaccine to pass through the skin.

A new study led by Mark Prausnitz, Ph.D., and Sean Sullivan, Ph.D., of Georgia Tech, and Dimitrios Koutsonanos, Ph.D., Ioanna Skountzou, Ph.D., and Richard Compans, Ph.D., of Emory University, compared microneedle patches to traditional hypodermic needles to vaccinate mice against the flu. The microneedles in this study were made of the polymer polyvinylpyrrolidone, a compound that has been previously tested and found to be nontoxic. The investigators found microneedles to be at least as effective as hypodermic needles, and by some measures, more so. The research was supported by NIAID and the National Institute of Biomedical Imaging and Bioengineering (NIBIB).

Microneedle Patches: A Melding of Engineering and Biology
Dr. Prausnitz’s lab has spent several years studying vaccine delivery. “Our goal is to use engineering technology to solve drug delivery problems,” he explains. “We want to administer vaccines in a way that would be easy for patients.”

The investigators used an innovative method to create the microneedle patches. In a process known as in situ polymerization, they mixed liquid vinylpyrrolidone with the vaccine, poured the mixture into a microneedle mold, and exposed it to ultraviolet light. This induced polymerization, creating much larger molecules.

Once placed on the skin, the microneedles pass through the surface skin layers, moisten, and dissolve, delivering flu vaccine to antigen-presenting cells in the skin. These cells then break down antigens and display them to other immune cells. The body mounts an immune response to those antigens, and is thereby prepared to fight off the virus in the future. When the microneedles fully dissolve – within a few minutes – the patch can be removed and disposed.

Testing Immunity from Microneedle-Delivered Vaccine
After vaccination, the researchers measured flu antibody levels in the blood and found no difference between mice who received the microneedle vaccine and those who received a hypodermic injection. In fact, when vaccinated mice were exposed to flu virus, those that received the microneedle vaccine were significantly better protected than those that received a hypodermic injection. Four days after being exposed, mice in the microneedle group were able to clear the virus out of their lungs 1000 times more efficiently than mice in the hypodermic group.

“Viral load is an important measure because it addresses the source of the problem: virus in the lungs. Microneedle vaccination brought the viral load in the lungs almost to zero,” says Dr. Prausnitz. A reduced viral load may also have implications for the infectivity of flu; if a person expels less virus with a cough or sneeze, transmission may be reduced.

Microneedle patches also have practical advantages over traditional hypodermic injections: they take up less space in clinics, do not require special disposal (as hypodermics do), are inexpensive to make, and may be simple enough for patients to self-administer at home. Because of these advantages, they could have important benefits for public health. If these results can be replicated in humans, not only would people who receive the vaccine be better protected from the flu, but it may be easier for more people to get vaccinated. If more people are vaccinated, fewer people are likely to get sick and be able to pass the virus on to others, lowering everyone’s chances of being exposed.

Looking to the Future
The researchers are currently exploring the reasons why microneedle delivery resulted in reduced viral load in mice. Microneedle skin patches target a different set of immune cells than conventional intramuscular injection, notes Dr. Prausnitz. “I don’t think the improvement in immunogenicity is something unique to microneedles, but rather is unique to delivery through the skin. Microneedles enable that to take place,” he says. In answering this question, they are studying the immunologic pathways triggered by delivery to the skin, and hoping to harness these pathways to improve immunogenicity.

They are also reaching out to experts in other infectious diseases, to test this delivery approach with different vaccines. Dr. Prausnitz cites the growing importance of collaboration in this research. “This study is one of more and more examples where the tools of engineering can be combined with the expertise of bioscientists, to obtain results that would have been hard to get without collaboration.”

Citation:
Sullivan SP, Koutsonanos DG, del Pilar Martin M, Lee J-W, Zarnitsyn V, Murthy N, Compans RW, Skountzou I, Prausnitz MR. (online, 18 July 2010). Dissolving polymer microneedle patches for influenza vaccination. Nature Medicine.
http://www.nature.com/nm/journal/vaop/ncurrent/abs/nm.2182.html

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Flu Shots No More?

Prevention and Control of Influenza with Vaccines

Prevention and Control of Influenza with Vaccines
Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010


Early Release
July 29, 2010 / 59(Early Release);1-62


Prepared by

Anthony E. Fiore, MD1

Timothy M. Uyeki, MD1

Karen Broder, MD2

Lyn Finelli, DrPH1

Gary L. Euler, DrPH3

James A. Singleton, MS3

John K. Iskander, MD4

Pascale M. Wortley, MD3

David K. Shay, MD1

Joseph S. Bresee, MD1

Nancy J. Cox, PhD1

1Influenza Division, National Center for Immunization and Respiratory Diseases

2Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Preparedness, Detection, and Control of Infectious Diseases

3Immunization Services Division, National Center for Immunization and Respiratory Diseases

4Office of the Associate Director for Science, Office of the Director



The material in this report originated in the National Center for Immunization and Respiratory Diseases, Anne Schuchat, MD, Director; the Influenza Division, Nancy Cox, PhD, Director; the Office of the Associate Director for Science, Harold Jaffe, MD, Director; the Immunization Safety Office, Division of Healthcare Quality Promotion, Denise Cardo, MD, Director; and the Immunization Services Division, Lance Rodewald, MD, Director.

Corresponding preparer: Timothy Uyeki, MD, Influenza Division, National Center for Immunization and Respiratory Diseases, CDC, 1600 Clifton Road, N.E., MS A-20, Atlanta, GA 30333. Telephone: 404-639-3747; Fax: 404-639-3866; E-mail: tuyeki@cdc.gov.



Summary
This report updates the 2009 recommendations by CDC's Advisory Committee on Immunization Practices (ACIP) regarding the use of influenza vaccine for the prevention and control of influenza (CDC. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2009;58[No. RR-8] and CDC. Use of influenza A (H1N1) 2009 monovalent vaccine---recommendations of the Advisory Committee on Immunization Practices [ACIP], 2009. MMWR 2009;58:[No. RR-10]). The 2010 influenza recommendations include new and updated information. Highlights of the 2010 recommendations include 1) a recommendation that annual vaccination be administered to all persons aged ≥6 months for the 2010--11 influenza season; 2) a recommendation that children aged 6 months--8 years whose vaccination status is unknown or who have never received seasonal influenza vaccine before (or who received seasonal vaccine for the first time in 2009--10 but received only 1 dose in their first year of vaccination) as well as children who did not receive at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine regardless of previous influenza vaccine history should receive 2 doses of a 2010--11 seasonal influenza vaccine (minimum interval: 4 weeks) during the 2010--11 season; 3) a recommendation that vaccines containing the 2010--11 trivalent vaccine virus strains A/California/7/2009 (H1N1)-like (the same strain as was used for 2009 H1N1 monovalent vaccines), A/Perth/16/2009 (H3N2)-like, and B/Brisbane/60/2008-like antigens be used; 4) information about Fluzone High-Dose, a newly approved vaccine for persons aged ≥65 years; and 5) information about other standard-dose newly approved influenza vaccines and previously approved vaccines with expanded age indications. Vaccination efforts should begin as soon as the 2010--11 seasonal influenza vaccine is available and continue through the influenza season. These recommendations also include a summary of safety data for U.S.-licensed influenza vaccines. These recommendations and other information are available at CDC's influenza website (http://www.cdc.gov/flu); any updates or supplements that might be required during the 2010--11 influenza season also will be available at this website. Recommendations for influenza diagnosis and antiviral use will be published before the start of the 2010--11 influenza season. Vaccination and health-care providers should be alert to announcements of recommendation updates and should check the CDC influenza website periodically for additional information.

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Prevention and Control of Influenza with Vaccines

Lot Release (Biologics) > 2010-2011 Vaccine Influenza Season Questions and Answers

2010-2011 Vaccine Influenza Season Questions and Answers

Key Facts

1. Vaccines for the 2010-2011 influenza season are approved by FDA for the prevention of influenza in children, adolescents, and adults, including the elderly.
There are several vaccines approved by FDA available in both nasal spray and injectable (a “shot”) forms.

2. Because the influenza viruses that cause people to get sick can change, each year's vaccine may be different from the previous year. Therefore, it is important to get the influenza vaccine every year.

3. The vaccines approved by FDA to protect against influenza have a long and successful track record of safety and effectiveness in the United States.

4. Influenza or “the flu” is a contagious respiratory illness caused by influenza viruses. It is a serious threat to public health and can cause mild to severe illness, and at times can lead to death.

5. The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommends that everyone 6 months of age and older receive the influenza vaccine every year.

6. The 2010-2011 seasonal influenza vaccine includes three strains; an A (H1N1) that is the same strain that is the cause of the pandemic that began in 2009, an A (H3N2) that is different than last year’s seasonal vaccine and a B strain that is the same as last year’s formulation.

7. This year, two different vaccines are not needed, only one. During last year’s influenza season, two different vaccines were needed; one to prevent seasonal influenza and another to prevent influenza that is the cause of the 2009 (H1N1) pandemic.

8. Each year there are two flu seasons due to the occurrence of influenza at different times in the Northern and Southern Hemispheres. Some influenza vaccine manufacturers produce vaccines for use in both the Northern Hemisphere and the Southern Hemisphere. The Southern Hemisphere vaccines are similar but not identical to the vaccines used in the Northern Hemisphere, which include the U.S. licensed vaccines.

9. In Australia and New Zealand, use of the 2010 Southern Hemisphere formulation of one influenza vaccine, manufactured by CSL Limited, has been associated with an increased incidence of fever and febrile seizure among young children, mainly among those less than 5 years of age. Therefore, the Warnings and Precautions section of the Prescribing Information for Afluria, the U.S. licensed Northern Hemisphere formulation made by CSL Limited, has been changed to include a statement to inform healthcare providers about the occurrence of these events.

10. The available data suggest that the increased rates of fever and febrile seizure in those children mainly less than 5 years of age, are only associated with the Southern Hemisphere formulation of CSL’s vaccine. The available data regarding the safety of other influenza vaccines for children used in the Southern Hemisphere do not suggest an increased rate of fever or febrile seizure.

11. FDA, in collaboration with CDC, will closely monitor the continued safety of all influenza vaccines.

Detailed Information:

What strains are included in the 2010-2011 seasonal influenza vaccine?

Each year, influenza infections are caused by Influenza A and Influenza B viruses. Three strains of influenza virus that cause people to get sick are included in the vaccine each year, a representative strain of Influenza A (H1N1), Influenza A (H3N2) and Influenza B. Because the influenza viruses that cause people to get sick can change, each year's vaccine may be different from the previous year.

This year, the B strain remains the same as last year’s seasonal vaccine, but the H1N1 and H3N2 strains are different. However, the H1N1 strain in this year’s vaccine is the same strain as the pandemic (H1N1) 2009 influenza virus.

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Lot Release (Biologics) > 2010-2011 Vaccine Influenza Season Questions and Answers

Blog.AIDS.gov - Highlights & Key Scientific Outcomes From Andrew Fullem

International AIDS Conference 2010: Highlights & Key Scientific Outcomes From Andrew Fullem

Guest post by Andrew Fullem, MSPH, AIDS.gov Advisor and Director for JSI & World Education's Center for HIV and AIDS


Andrew Fullem, MSPH, AIDS.gov Advisor and Director for JSI & World Education's Center for HIV and AIDS

I’ve been fortunate to attend international HIV conferences for many years. Several of those conferences stand out in my memory for the results they produced. In Vancouver (1996), researchers first announced the results of the highly active antiretroviral therapy (HAART) clinical trials—changing the future for millions of us living with HIV. In Durban (2000), delegates to the conference made an urgent call to ensure access to treatment for people in Africa and other regions of the world heavily impacted by HIV. Now the XVIII International AIDS Conference which recently concluded in Vienna joins that list for memorable results. On Monday, July 19, researchers announced a significant step forward in the development of microbicides that may one day be widely available to provide critical protection from HIV and herpes.

It was an amazing few days with scientists, service providers, clients, and advocates talking and debating about what we need to do for those living with, and at risk for, HIV. Some of the highlights for me include:

For many years, scientists and communities have been testing new products that combine antiretrovirals (ARVs) with prevention products to stop transmission of HIV. Microbicides are one of those products. In the CAPRISA study (PDF, 263 KB) that was featured at the conference, the investigational vaginal microbicide gel contained the antiretroviral drug tenofovir, and women in the study were instructed to use the gel before and after sex to protect against HIV transmission.

The study results found that the gel was 39% effective in reducing a woman’s risk of becoming infected with HIV during sex and 51% effective in preventing genital herpes infections in the women participating in the trial. Additional clinical research is needed to further confirm the effectiveness of this gel, but these initial results are great news. An effective microbicide gel could help women protect themselves against HIV infection and could prevent millions of new HIV infections.

Children and adolescents living with HIV: Studies in the U.S., Europe, and Africa further demonstrated that children and adolescents living with HIV have unique needs and need specific and tailored support as they mature to help them develop and deal with their HIV disease and related issues (e.g., disclosure, healthy relationships, body image), as well as to help them maintain treatment adherence and to plan for a productive future.

Cancer and HIV: The news on this front was mixed. The U.S. National Cancer Institute, part of the NIH, reported that the incidence of some cancers commonly associated with HIV (e.g., Kaposi’s sarcoma, non-Hodgkin’s lymphoma) has decreased. Unfortunately, a number of other cancers (e.g., lung, Hodgkin’s lymphoma, anal) are on the rise among people living with HIV. These findings highlight the need to ensure that appropriate cancer screening is fully integrated into clinical care for people living with HIV.

HIV Treatment:The question of when to start ART was a key topic for discussion. The International AIDS Society–USA Panel released new recommendations calling for patients to begin receiving treatment earlier in the course of infection. The guidelines also emphasized that clients need to be ready to start therapy and willing to adhere to lifelong treatment.

Another important treatment discussion focused on selecting HIV meds for people co-infected with HIV and hepatitis C. Studies presented at the conference showed that people with co-infection who took nevirapine as part of their ARV regimen responded better to hepatitis treatment using interferon.

There is no way I can do justice to all that I learned in Vienna. These findings are my highlights—but you can learn more from AIDS.gov and other websites about the advances we have made and the challenges ahead. I left Vienna excited about the way forward and honored to be part of the HIV community!

Andrew Fullem, MSPH, is an advisor to AIDS.gov and serves as the Director for John Snow, Inc. (JSI) & World Education's Center for HIV and AIDS. In 2007, he was appointed to the Global Fund’s Communities Living with HIV and TB Support Delegation.
Blog.AIDS.gov

Safety Alerts for Human Medical Products > Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach

Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach

AUDIENCE: Consumers, Emergency Medicine

ISSUE: FDA warned consumers not to consume or use Miracle Mineral Solution, an oral liquid solution also known as "Miracle Mineral Supplement" or "MMS." The product, when used as directed, produces an industrial bleach that can cause serious harm to health. The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.

BACKGROUND: MMS is distributed on Internet sites and online auctions by multiple independent distributors. MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer, and other conditions. The FDA is not aware of any research that MMS is effective in treating any of these conditions. MMS also poses a significant health risk to consumers who may choose to use this product for self-treatment instead of seeking FDA-approved treatments for these conditions.

RECOMMENDATIONS: Consumers who have MMS should stop using it immediately and throw it away. The FDA advises consumers who have experienced any negative side effects from MMS to consult a health care professional as soon as possible.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Online: www.fda.gov/MedWatch/report.htm
Phone: 1-800-332-1088
Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
Fax: 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA News Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220756.htm

Safety Alerts for Human Medical Products > Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach

Safety Alerts for Human Medical Products > Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure

Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure

AUDIENCE: Pediatrics, Family Practice

ISSUE: FDA updated the Warnings and Precautions sections of the Prescribing Information for Afluria to inform healthcare professionals that the Afluria vaccine has been associated with an increased incidence of fever and febrile seizure among young children reported in Australia, mainly among those less than 5 years of age.

BACKGROUND: FDA announced the approved vaccines for the 2010-2011 influenza season in the United States. The brand names and manufacturers for the upcoming season’s vaccines are: Afluria, CSL Limited; Agriflu, Novartis Vaccines and Diagnostics; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; FluMist, MedImmune Vaccines Inc.; Fluvirin, Novartis Vaccines and Diagnostics Limited; and Fluzone and Fluzone High-Dose, Sanofi Pasteur Inc.

The available data suggest that the increased rates of fever and febrile seizure are only associated with the Southern Hemisphere formulation of CSL’s vaccine. The available data regarding the safety of other influenza vaccines for children used in the Southern Hemisphere do not suggest an increased rate of fever or febrile seizure. FDA is requiring CSL Limited to conduct a study of Afluria in children to obtain additional information regarding the febrile events that were seen in the Southern Hemisphere. CSL Limited will not be supplying the United States with the 0.25 milliliter single-dose, prefilled syringes, which are used in very young children. The 0.5 milliliter single-dose, prefilled syringes and 5 milliliter multi-dose vials will be distributed.

RECOMMENDATION: Vaccines for the 2010-2011 influenza season are approved by FDA for the prevention of influenza in children, adolescents, and adults, including the elderly. There are several vaccines approved by FDA available in both nasal spray and injectable (“shot”) forms. Because the influenza viruses that cause people to get sick can change, each year's vaccine may be different from the previous year. Therefore, it is important to get the influenza vaccine every year.

Various investigations into the cause(s) of the febrile seizures seen with Afluria vaccine are still ongoing. FDA is collaborating with Australia’s regulatory authority, other international regulatory counterparts, and CSL to obtain additional information, stay apprised and take part in the investigations. FDA, in collaboration with CDC, will closely monitor the continued safety of all influenza vaccines.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the Vaccine Adverse Events Reporting System, a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention and the Food and Drug Administration.
Read the MedWatch safety alert, including links to FDA Q&As, News Release, Product Page, and the Package Insert, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220764.htm
Safety Alerts for Human Medical Products > Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure